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1.
Ann Surg Oncol ; 31(8): 5340-5351, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38704501

ABSTRACT

BACKGROUND: Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM. METHODS: Eligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS). RESULTS: The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44-47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed. CONCLUSION: Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).


Subject(s)
Antineoplastic Agents, Alkylating , Liver Neoplasms , Melanoma , Melphalan , Uveal Neoplasms , Humans , Melanoma/drug therapy , Melanoma/pathology , Melanoma/secondary , Melanoma/mortality , Melphalan/administration & dosage , Male , Female , Middle Aged , Uveal Neoplasms/drug therapy , Uveal Neoplasms/pathology , Uveal Neoplasms/mortality , Aged , Adult , Survival Rate , Liver Neoplasms/secondary , Liver Neoplasms/drug therapy , Follow-Up Studies , Antineoplastic Agents, Alkylating/administration & dosage , Antineoplastic Agents, Alkylating/therapeutic use , Prognosis , Aged, 80 and over , Drug Delivery Systems
2.
J Vasc Interv Radiol ; 34(9): 1547-1555, 2023 09.
Article in English | MEDLINE | ID: mdl-37210030

ABSTRACT

PURPOSE: To evaluate the safety and effectiveness of yttrium-90 (90Y) radioembolization as first-line treatment for unresectable intrahepatic cholangiocarcinoma (ICC). MATERIALS AND METHODS: This prospective study enrolled patients who had never received chemotherapy, liver embolization, and radiation therapy. The tumors were solitary in 16 patients, multiple in 8 patients, unilobar in 14 patients, and bilobar in 10 patients. Patients underwent transarterial radioembolization with 90Y-labeled glass microspheres. The primary end point was hepatic progression-free survival (HPFS). Secondary end points were overall survival (OS), tumor response, and toxicity. RESULTS: Twenty-four patients (age, 72.3 years ± 9.3; 12 women) were included in the study. The median delivered radiation dose was 135.5 Gy (interquartile range, 77.6 Gy). The median HPFS was 5.5 months (95% CI, 3.9-7.0 months). Analysis failed to identify any prognostic factor associated with HPFS. Imaging response at 3 months showed 56% disease control, and the best radiographic response was 71% disease control. The median OS from the radioembolization treatment was 19.4 months (95% CI, 5.0-33.7). Patients with solitary ICC had significantly longer median OS than patients with multifocal ICC: 25.9 months (95% CI, 20.8-31.0 months) versus 10.7 months (95% CI, 8.0-13.4 months) (P = .02). Patients with progression on the 3-month imaging follow-up had significantly shorter median OS than patients who had stable disease at 3 months: 10.7 months (95% CI, 0.7-20.7 months) versus 37.3 months (95% CI, 16.5-58.1 months) (P = .003). Two (8%) Grade 3 toxicities were reported. CONCLUSIONS: First-line treatment of ICC with radioembolization showed promising OS and minimal toxicity, especially in patients with solitary tumor. Radioembolization may be considered as a first-line treatment option for unresectable ICC.


Subject(s)
Bile Duct Neoplasms , Cholangiocarcinoma , Embolization, Therapeutic , Liver Neoplasms , Humans , Female , Aged , Prospective Studies , Bile Ducts, Intrahepatic , Microspheres , Feasibility Studies , Treatment Outcome , Cholangiocarcinoma/diagnostic imaging , Cholangiocarcinoma/radiotherapy , Yttrium Radioisotopes , Embolization, Therapeutic/methods , Bile Duct Neoplasms/diagnostic imaging , Bile Duct Neoplasms/radiotherapy , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/radiotherapy
3.
Ann Surg Oncol ; 28(6): 3366-3374, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33073344

ABSTRACT

BACKGROUND: Resecting non-palpable soft tissue tumors presents a unique challenge, particularly with recurrent disease in which surrounding tissue has been surgically manipulated and often irradiated. SAVI SCOUT® is a radar-based localization device that was developed for breast tumor localization and was recently FDA-approved for localization of soft tissue tumors. Application of this technology to soft tissue sarcoma has not been previously reported. METHODS: We assembled a single-institution retrospective case series of patients with trunk and extremity sarcomas resected by five sarcoma surgeons using SAVI SCOUT® from December 2018 to May 2020. Reflectors were placed preoperatively using image-guidance, and the radar detector was used intraoperatively to localize the target lesion. Clinical variables were abstracted from the electronic medical record including treatment history, pathology, and early oncologic outcomes. Using a focused review, we compared margin status and recurrence rates with previously published cohorts. RESULTS: Ten SAVI SCOUT®-localized sarcoma resections were performed. Eight were for locally recurrent disease, of which seven (83%) had prior radiation. The remaining lesions became non-palpable after neoadjuvant chemotherapy. SAVI SCOUT® facilitated resection in all cases with a margin-negative resection rate (77%) comparable to prior cohorts. In this high-risk population with a median follow-up of 14 months, only one patient recurred locally 7.5 months after SAVI SCOUT®-localized resection, requiring re-resection. CONCLUSION: SAVI SCOUT® technology facilitated resection of non-palpable recurrent sarcoma of the trunk and extremities in all ten cases attempted. In a high-risk patient population, the pattern of recurrence has been primarily distant with one instance of local tumor recurrence.


Subject(s)
Sarcoma , Soft Tissue Neoplasms , Extremities/surgery , Humans , Neoplasm Recurrence, Local/surgery , Radar , Retrospective Studies , Sarcoma/diagnostic imaging , Sarcoma/surgery
4.
Cancer Control ; 27(1): 1073274820983019, 2020.
Article in English | MEDLINE | ID: mdl-33372814

ABSTRACT

Patients with unresectable hepatic metastases, from uveal or ocular melanoma, are challenging to treat with an overall poor prognosis. Although over the past decade significant advances in systemic therapies have been made, metastatic disease to the liver, especially from uveal melanoma, continues to be a poor prognosis. Percutaneous hepatic perfusion (PHP) is a safe, viable treatment option for these patients. PHP utilizes high dose chemotherapy delivered directly to the liver while minimizing systemic exposure and can be repeated up to 6 times. Isolation of the hepatic vasculature with a double-balloon catheter allows for high concentration cytotoxic therapy to be administered with minimal systemic adverse effects. A detailed description of the multidisciplinary treatment protocol used at an institution with over 12 years of experience is discussed and recommendations are given. A dedicated team of a surgical or medical oncology, interventional radiology, anesthesiology and a perfusionist allows PHP to be repeatedly performed as a safe treatment strategy for unresectable hepatic metastases.


Subject(s)
Antineoplastic Agents, Alkylating/administration & dosage , Chemotherapy, Cancer, Regional Perfusion/methods , Liver Neoplasms/drug therapy , Melanoma/pathology , Skin Neoplasms/pathology , Uveal Neoplasms/pathology , Aged , Antineoplastic Agents, Alkylating/adverse effects , Chemotherapy, Cancer, Regional Perfusion/adverse effects , Female , Humans , Liver/blood supply , Liver/diagnostic imaging , Liver/drug effects , Liver/pathology , Liver Neoplasms/mortality , Liver Neoplasms/secondary , Male , Medical Oncology/organization & administration , Melanoma/drug therapy , Melanoma/mortality , Melphalan/administration & dosage , Melphalan/adverse effects , Middle Aged , Patient Care Team/organization & administration , Phlebography , Progression-Free Survival , Radiology, Interventional/organization & administration , Skin Neoplasms/drug therapy , Skin Neoplasms/mortality , Uveal Neoplasms/drug therapy , Uveal Neoplasms/mortality
5.
J Vasc Interv Radiol ; 31(7): 1060-1068, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32534978

ABSTRACT

PURPOSE: To retrospectively evaluate the safety and efficacy of transarterial radioembolization (TARE) with yttrium-90 (90Y)-labeled glass microspheres in pancreatic adenocarcinoma patients with liver-dominant metastatic disease. MATERIALS AND METHODS: This retrospective, single-center study evaluated 26 patients (12 men and 14 women; mean age, 65.5 ± 11.2 years) with liver-dominant metastatic pancreatic cancer who were treated with TARE from April 2010 to September 2017. All patients received systemic chemotherapy before TARE, and 19 received systemic therapy after embolization. Nineteen patients had extrahepatic disease at the time of TARE. Response to treatment was determined by Response Evaluation Criteria in Solid Tumors at 3 months. RESULTS: Median overall survival (OS) from pancreatic cancer diagnosis was 33.0 months (range, 8.5-87.5 months); median OS from diagnosis of liver metastasis was 21.8 months (range, 2.0-86.2 months); and median OS from TARE treatment was 7.0 months (range, 1.0-84.1 months). Grade 1-2 clinical toxicities were noted in 21 patients (80.8%), and 24 patients (92.3%) had grade 1-2 biochemical toxicities. Four patients (15.4%) had grade 3 clinical toxicities, and 6 patients (23.1%) had grade 3 biochemical toxicities. Imaging was available in 22 patients (84.6%) and demonstrated partial response in 1 patient, stable disease in 9 patients, and progressive disease in 12 patients. Improved hepatic progression-free survival was associated in patients younger than 65 years and in those whose carbohydrate antigen 19-9 level decreased or remained stable after treatment. CONCLUSIONS: TARE with 90Y-labeled glass microspheres is safe and led to promising OS in liver-dominant metastatic pancreatic cancer.


Subject(s)
Adenocarcinoma/radiotherapy , Embolization, Therapeutic , Pancreatic Neoplasms/pathology , Radiopharmaceuticals/administration & dosage , Yttrium Radioisotopes/administration & dosage , Adenocarcinoma/diagnostic imaging , Adenocarcinoma/mortality , Adenocarcinoma/secondary , Aged , Disease Progression , Embolization, Therapeutic/adverse effects , Embolization, Therapeutic/mortality , Female , Glass , Humans , Male , Microspheres , Middle Aged , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/mortality , Progression-Free Survival , Radiopharmaceuticals/adverse effects , Retrospective Studies , Time Factors , Yttrium Radioisotopes/adverse effects
6.
J Vasc Interv Radiol ; 31(4): 584-591, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31471193

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of partial splenic embolization (PSE) in cancer patients with different etiologies of splenomegaly/hypersplenism. MATERIALS AND METHODS: The medical records of 35 cancer patients who underwent 39 PSE procedures were analyzed. The splenomegaly/hypersplenism was due to chemotherapy (n = 17), portal hypertension (n = 10), or hematologic malignancy (n = 8). After the first 11 PSEs, celiac plexus neurolysis, corticosteroids, and non-steroid anti-inflammatory drugs (NSAIDs) were included in the post-procedural management. RESULTS: PSE led to 59 ± 16% (mean ± standard deviation) splenic infarcts. The infarct volume per 1 mL 300-500 µm tris-acryl gelatin microspheres was not significantly different between the chemotherapy-induced group (264 ± 89 cm3) and the portal hypertension group (285 ± 139 cm3) but was significantly higher in the hematology group (582 ± 345 cm3). Platelet count increased from 65.7 ± 19.7 k/µl to a peak platelet count of 221 ± 83 k/µl at 2 weeks after PSE. Patients with a follow-up period of more than 1 year had the most recent platelet count of 174 ± 113 k/µl. Platelet count increase was significantly higher in the chemotherapy-induced group than the portal hypertension group. Adding celiac plexus neurolysis, corticosteroids, and NSAIDs to the post-procedural management resulted in a decreased rate of major complications from 73% to 46% and a decrease in the rate of moderate or severe pain from 92% to 20%. CONCLUSIONS: PSE improved platelet counts in cancer patients despite different etiologies of splenomegaly. The addition of celiac plexus neurolysis, corticosteroids, and NSAIDS to the post-PSE treatment protocol reduced complications. Data from this study could help to predict the amount of 300-500 µm tris-acryl gelatin microspheres required to achieve a planned infarct size.


Subject(s)
Antineoplastic Agents/adverse effects , Embolization, Therapeutic , Hypertension, Portal/etiology , Neoplasms/drug therapy , Portal Pressure , Splenic Artery , Splenomegaly/therapy , Aged , Blood Platelets , Embolization, Therapeutic/adverse effects , Female , Hematologic Neoplasms/complications , Humans , Hypertension, Portal/diagnosis , Hypertension, Portal/physiopathology , Male , Middle Aged , Neoplasms/complications , Retrospective Studies , Splenic Artery/diagnostic imaging , Splenomegaly/blood , Splenomegaly/diagnostic imaging , Splenomegaly/etiology , Time Factors , Treatment Outcome
9.
J Surg Res ; 237: 12-21, 2019 05.
Article in English | MEDLINE | ID: mdl-30694786

ABSTRACT

BACKGROUND: The obesity epidemic has prompted the need to better understand the impact of adipose tissue on human pathophysiology. However, accurate, efficient, and replicable models of quantifying adiposity have yet to be developed and clinically implemented. We propose a novel semiautomated radiologic method of measuring the visceral fat area (VFA) using computed tomography scan analysis. MATERIALS AND METHODS: We obtained a cohort of 100 patients with rectal adenocarcinoma, with a median age of 60.9 y (age range: 35-87 y) and an average body mass index of 28.8 kg/m2 ± 6.56 kg/m2. The semiautomated quantification method of adiposity was developed using a commercial imaging suite. The method was compared to two manual delineations performed using two different picture archiving communication systems. We quantified VFA, subcutaneous fat area (SFA), total fat area (TFA), and visceral-to-subcutaneous fat ratio (V/S ratio) on computed tomography axial slices that were at the L4-L5 intervertebral level. RESULTS: The semiautomated method was comparable to manual measurements for TFA, VFA, and SFA with intraclass correlation (ICC) of 0.99, 0.97, and 0.96, respectively. However, the ICC for the V/S ratio was only 0.44, which led to the identification of technical outliers that were identified using robust regression. After removal of these outliers, the ICC improved to 0.99 for TFA, VFA, and SFA and 0.97 for the V/S ratio. Measurements from the manual methodology highly correlated between the two picture archiving communication system platforms, with ICC of 0.98 for TFA, 0.98 for VFA, 0.96 for SFA, and 0.95 for the V/S ratio. CONCLUSIONS: This semiautomated method is able to generate precise and reproducible results. In the future, this method may be applied on a larger scale to facilitate risk stratification of patients using measures of abdominal adiposity.


Subject(s)
Adenocarcinoma/diagnostic imaging , Adiposity , Image Processing, Computer-Assisted/methods , Obesity/diagnosis , Rectal Neoplasms/diagnostic imaging , Adenocarcinoma/complications , Adult , Aged , Aged, 80 and over , Algorithms , Body Mass Index , Female , Humans , Intra-Abdominal Fat/diagnostic imaging , Male , Middle Aged , Obesity/complications , Rectal Neoplasms/complications , Risk Assessment/methods , Subcutaneous Fat/diagnostic imaging , Tomography, X-Ray Computed
10.
J Surg Oncol ; 117(6): 1170-1178, 2018 May.
Article in English | MEDLINE | ID: mdl-29284076

ABSTRACT

BACKGROUND: Metastatic uveal melanoma (UM) carries a poor prognosis; liver is the most frequent and often solitary site of recurrence. Available systemic treatments have not improved outcomes. Melphalan percutaneous hepatic perfusion (M-PHP) allows selective intrahepatic delivery of high dose cytotoxic chemotherapy. METHODS: Retrospective analysis of outcomes data of UM patients receiving M-PHP at two institutions was performed. Tumor response and toxicity were evaluated using RECIST 1.1 and Common Terminology Criteria for Adverse Events (CTCAE) v4.03, respectively. RESULTS: A total of 51 patients received 134 M-PHP procedures (median of 2 M-PHPs). 25 (49%) achieved a partial (N = 22, 43.1%) or complete hepatic response (N = 3, 5.9%). In 17 (33.3%) additional patients, the disease stabilized for at least 3 months, for a hepatic disease control rate of 82.4%. After median follow-up of 367 days, median overall progression free (PFS) and hepatic progression free survival (hPFS) was 8.1 and 9.1 months, respectively and median overall survival was 15.3 months. There were no treatment related fatalities. Non-hematologic grade 3-4 events were seen in 19 (37.5%) patients and were mainly coagulopathic (N = 8) and cardiovascular (N = 9). CONCLUSIONS: M-PHP results in durable intrahepatic disease control and can form the basis for an integrated multimodality treatment approach in appropriately selected UM patients.


Subject(s)
Antineoplastic Agents, Alkylating/administration & dosage , Chemotherapy, Cancer, Regional Perfusion , Liver Neoplasms/drug therapy , Melanoma/drug therapy , Melphalan/administration & dosage , Rare Diseases/drug therapy , Uveal Neoplasms/drug therapy , Adult , Aged , Female , Follow-Up Studies , Humans , Liver Neoplasms/secondary , Male , Melanoma/pathology , Middle Aged , Prognosis , Rare Diseases/pathology , Retrospective Studies , Survival Rate , Uveal Neoplasms/pathology
11.
J Vasc Interv Radiol ; 29(8): 1101-1108, 2018 08.
Article in English | MEDLINE | ID: mdl-30042074

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of transarterial yttrium-90 glass microsphere radioembolization in patients with unresectable intrahepatic cholangiocarcinoma (ICC). MATERIALS AND METHODS: Retrospective review of 85 consecutive patients (41 men and 44 women; age, 73.4 ± 9.3 years) was performed. Survival data were analyzed by the Kaplan-Meier method, Cox regression models, and the log-rank test. RESULTS: Median overall survival (OS) from diagnosis was 21.4 months (95% confidence interval [CI]: 16.6-28.4); median OS from radioembolization was 12.0 months (95% CI: 8.0-15.2). Seven episodes of severe toxicity occurred. At 3 months, 6.2% of patients had partial response, 64.2% had stable disease, and 29.6% had progressive disease. Median OS from radioembolization was significantly longer in patients with Eastern Cooperative Oncology Group (ECOG) scores of 0 and 1 than patients with an ECOG score of 2 (18.5 vs 5.5 months, P = .0012), and median OS from radioembolization was significantly longer in patients with well-differentiated histology than patients with poorly differentiated histology (18.6 vs 9.7 months, P = .012). Patients with solitary tumors had significantly longer median OS from radioembolization than patients with multifocal disease (25 vs. 6.1 months, P = .006). The absence of extrahepatic metastasis was associated with significantly increased median OS (15.2 vs. 6.8 months, P = .003). Increased time from diagnosis to radioembolization was a negative predictor of OS. The morphology of the tumor (mass-forming or infiltrative, hyper- or hypo-enhancing) had no effect on survival. Post-treatment increased cancer antigen 19-9 level, increased international normalized ratio, decreased albumin, increased bilirubin, increased aspartate aminotransferase, and increased Model for End-Stage Liver Disease score were significant predictors of decreased OS. CONCLUSIONS: These data support the therapeutic role of radioembolization for the treatment of unresectable ICC with good efficacy and an acceptable safety profile.


Subject(s)
Bile Duct Neoplasms/radiotherapy , Cholangiocarcinoma/radiotherapy , Embolization, Therapeutic/methods , Radiopharmaceuticals/administration & dosage , Yttrium Radioisotopes/administration & dosage , Aged , Aged, 80 and over , Aspartate Aminotransferases/blood , Bile Duct Neoplasms/blood , Bile Duct Neoplasms/mortality , Bile Duct Neoplasms/pathology , Bilirubin/blood , CA-19-9 Antigen/blood , Cholangiocarcinoma/blood , Cholangiocarcinoma/mortality , Cholangiocarcinoma/pathology , Embolization, Therapeutic/adverse effects , Embolization, Therapeutic/mortality , Female , Glass , Humans , International Normalized Ratio , Kaplan-Meier Estimate , Male , Microspheres , Middle Aged , Multivariate Analysis , Proportional Hazards Models , Radiopharmaceuticals/adverse effects , Retrospective Studies , Risk Factors , Serum Albumin, Human/metabolism , Time Factors , Treatment Outcome , Yttrium Radioisotopes/adverse effects
12.
Cancer Control ; 24(5): 1073274817729076, 2017.
Article in English | MEDLINE | ID: mdl-28975822

ABSTRACT

BACKGROUND: Pancreatic neuroendocrine tumors (PanNETs) constitute approximately 3% of pancreatic neoplasms. Like patients with pancreatic ductal adenocarcinoma (PDAC), some of these patients present with "borderline resectable disease." For these patients, an optimal treatment approach is lacking. We report our institution's experience with borderline resectable PanNETs using multimodality treatment. METHODS: We identified patients with borderline resectable PanNETs who had received neoadjuvant therapy at our institution between 2000 and 2013. The definition of borderline resectability was based on National Comprehensive Cancer Network criteria for PDAC. Neoadjuvant regimen, radiographic response, pathologic response, surgical margins, nodal retrieval, number of positive nodes, and recurrence were documented. Statistics were descriptive. RESULTS: Of 112 patients who underwent surgical resection for PanNETs during the study period, 23 received neoadjuvant therapy, 6 of whom met all inclusion criteria and had borderline resectable disease. These 6 patients received at least 1 cycle of temozolomide and capecitabine, with 3 also receiving radiation. All had radiographic evidence of treatment response. Four (67%) had negative-margin resections. Four patients had histologic evidence of a moderate response. Follow-up (3.0-4.3 years) indicated that all patients were alive, with 5/6 free of disease (1 patient with metastatic disease still on treatment without progression). CONCLUSIONS: A multimodality treatment strategy (neoadjuvant temozolomide and capecitabine ± radiation) can be successfully applied to patients with PanNETs who meet NCCN borderline resectable criteria for PDAC. To our knowledge, this is the first report of the use of a multimodality protocol in the treatment of patients with borderline resectable PanNETs.


Subject(s)
Neuroendocrine Tumors/drug therapy , Pancreatic Neoplasms/drug therapy , Adult , Aged , Female , Humans , Male , Middle Aged , Neuroendocrine Tumors/pathology , Pancreatic Neoplasms/pathology , Young Adult
13.
Cancer Control ; 24(3): 1073274817729244, 2017.
Article in English | MEDLINE | ID: mdl-28975829

ABSTRACT

Hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (IHC) are primary liver cancers where all or most of the tumor burden is usually confined to the liver. Therefore, locoregional liver-directed therapies can provide an opportunity to control intrahepatic disease with minimal systemic side effects. The English medical literature and clinical trials were reviewed to provide a synopsis on the available liver-directed percutaneous therapies for HCC and IHC. Locoregional liver-directed therapies provide survival benefit for patients with HCC and IHC compared to best medical treatment and have lower comorbid risks compared to surgical resection. These treatment options should be considered, especially in patients with unresectable disease.


Subject(s)
Carcinoma, Hepatocellular/therapy , Chemoembolization, Therapeutic/methods , Liver Neoplasms/therapy , Carcinoma, Hepatocellular/pathology , Cholangiocarcinoma , Humans , Liver Neoplasms/pathology
14.
J Vasc Interv Radiol ; 28(2): 254-259, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27955832

ABSTRACT

PURPOSE: To evaluate safety and efficacy of transarterial hepatic radioembolization treatment of patients with liver-dominant metastatic renal cell carcinoma (RCC). MATERIALS AND METHODS: From July 2010 to December 2014, 18 patients with liver-dominant metastatic RCC were treated with yttrium-90 glass microsphere radioembolization. Retrospective review of medical records and imaging studies was performed to evaluate toxicities, treatment response, and overall survival. The median follow-up period from radioembolization treatment was 17.8 months (range, 3-54.4 months). RESULTS: Median overall survival from RCC diagnosis was 64 months (95% confidence interval [CI], 0-144.1 months), from diagnosis of liver metastasis was 29 months (95% CI, 7.2-50.8 months), and from radioembolization treatment was 22.8 months (95% CI, 13.2-32.3 months). After treatment, 10 patients reported grade 1 clinical toxicities, and 8 patients had grade 1 or 2 biochemical toxicities. The best radiographic responses of 17 patients who underwent contrast-enhanced cross-sectional imaging showed complete response in 16 patients and partial response in 1 patient evaluated by modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. The last available imaging of these 17 patients demonstrated complete response in 14 patients, partial response in 1 patient, and progression of disease in 2 patients. Images of a patient who underwent noncontrast CT showed stable disease as best response and stable disease on the last available imaging evaluated by RECIST. CONCLUSIONS: Radioembolization is safe and effective and led to improved hepatic disease control and overall survival in patients with liver-dominant metastatic RCC.


Subject(s)
Carcinoma, Renal Cell/secondary , Carcinoma, Renal Cell/therapy , Embolization, Therapeutic/methods , Kidney Neoplasms/pathology , Liver Neoplasms/secondary , Liver Neoplasms/therapy , Radiopharmaceuticals/administration & dosage , Yttrium Radioisotopes/administration & dosage , Aged , Aged, 80 and over , Carcinoma, Renal Cell/diagnostic imaging , Carcinoma, Renal Cell/mortality , Embolization, Therapeutic/adverse effects , Embolization, Therapeutic/mortality , Female , Humans , Kaplan-Meier Estimate , Kidney Neoplasms/mortality , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/mortality , Male , Middle Aged , Radiopharmaceuticals/adverse effects , Retrospective Studies , Risk Factors , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , Yttrium Radioisotopes/adverse effects
15.
Ann Surg Oncol ; 23(4): 1309-19, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26597368

ABSTRACT

PURPOSE: There is no consensus for the treatment of melanoma metastatic to the liver. Percutaneous hepatic perfusion with melphalan (PHP-Mel) is a method of delivering regional chemotherapy selectively to the liver. In this study, we report the results of a multicenter, randomized controlled trial comparing PHP-Mel with best alternative care (BAC) for patients with ocular or cutaneous melanoma metastatic to the liver. PATIENTS AND METHODS: A total of 93 patients were randomized to PHP-Mel (n = 44) or BAC (n = 49). On the PHP-Mel arm, melphalan was delivered via the hepatic artery, and the hepatic effluent captured and filtered extracorporeally prior to return to the systemic circulation via a venovenous bypass circuit. PHP-Mel was repeatable every 4-8 weeks. The primary endpoint was hepatic progression-free survival (hPFS), and secondary endpoints included overall PFS (oPFS), overall survival (OS), hepatic objective response (hOR), and safety. RESULTS: hPFS was 7.0 months for PHP-Mel and 1.6 months for BAC (p < 0.0001), while oPFS was 5.4 months for PHP-Mel and 1.6 months for BAC (p < 0.0001). Median OS was not significantly different (PHP-Mel 10.6 months vs. BAC 10.0 months), likely due to crossover to PHP-Mel treatment (57.1 %) from the BAC arm, and the hOR was 36.4 % for PHP-Mel and 2.0 % for BAC (p < 0.001). The majority of adverse events were related to bone marrow suppression. Four deaths were attributed to PHP-Mel, three in the primary PHP-Mel group, and one post-crossover to PHP-Mel from BAC. CONCLUSION: This randomized, phase III study demonstrated the efficacy of the PHP-Mel procedure. hPFS, oPFS, and hOR were significantly improved with PHP-Mel. PHP with melphalan should provide a new treatment option for unresectable metastatic melanoma in the liver.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Eye Neoplasms/secondary , Hepatic Artery , Liver Neoplasms/secondary , Melanoma/pathology , Skin Neoplasms/secondary , Adult , Aged , Chemotherapy, Cancer, Regional Perfusion , Embolization, Therapeutic , Eye Neoplasms/drug therapy , Female , Follow-Up Studies , Humans , Infusions, Intra-Arterial , Liver Neoplasms/drug therapy , Male , Melanoma/drug therapy , Middle Aged , Neoplasm Staging , Perfusion , Prognosis , Skin Neoplasms/drug therapy , Survival Rate
16.
Surg Endosc ; 29(11): 3273-81, 2015 Nov.
Article in English | MEDLINE | ID: mdl-25631110

ABSTRACT

BACKGROUND: We evaluated whether preoperative biliary drainage was predictive of recurrence and survival among patients with resectable pancreatic cancer. METHODS: Patients with pancreatic cancer who were treated with upfront surgery between 2000 and 2012 were identified and stratified by preoperative percutaneous transhepatic cholangiogram-guided drainage (PTBD), placement of endoscopic stents (ERCP), or no biliary drainage (NBD). The primary endpoint was overall survival. RESULTS: We identified 193 patients with resectable pancreatic head cancer (33 PTBD; 96 ERCP; and 64 NBD). Key differences between the three groups were more patients who underwent >1 preoperative biliary procedures (p = 0.004) in the PTBD cohort. PTBD patients had a significant increase in hepatic recurrence rate compared with patients who did not undergo PTBD (44.8 vs. 23.3 %, p = 0.02). PTBD patients also had worse overall survival. Median and 5-year survival for PTBD, ERCP, and NBD patients were 17.5 months and 3 %, 22.4 months and 24 %, and 28.9 months and 32 %, respectively (p = 0.002). MVA revealed that percutaneous drainage was an independent predictor of worse overall survival [HR 1.76, 95 % CI (1.05-2.99), p = 0.03]. CONCLUSIONS: Patients with resectable pancreatic cancer who receive PTBD have more advanced disease, higher hepatic recurrence, and worse survival.


Subject(s)
Drainage , Pancreatectomy , Pancreatic Neoplasms/surgery , Preoperative Care , Adult , Aged , Aged, 80 and over , Cholangiography , Drainage/methods , Female , Humans , Liver Neoplasms/secondary , Male , Middle Aged , Neoplasm Recurrence, Local/etiology , Pancreatic Neoplasms/diagnostic imaging , Pancreatic Neoplasms/mortality , Pancreatic Neoplasms/pathology , Preoperative Care/methods , Retrospective Studies , Stents , Treatment Outcome
17.
J Surg Oncol ; 109(5): 434-9, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24249545

ABSTRACT

BACKGROUND: Patients with unresectable melanoma or sarcoma hepatic metastasis have a poor prognosis with few therapeutic options. Percutaneous hepatic perfusion (PHP), isolating and perfusing the liver with chemotherapy, provides a promising minimally invasive management option. We reviewed our institutional experience with PHP. METHODS: We retrospectively reviewed patients with unresectable melanoma or sarcoma hepatic metastasis treated with PHP from 2008 to 2013 and evaluated therapeutic response, morbidity, hepatic progression free survival (hPFS), and overall survival (OS). RESULTS: Ten patients were treated with 27 PHPs (median 3). Diagnoses were ocular melanoma (n = 5), cutaneous melanoma (n = 3), unknown primary melanoma (n = 1), and sarcoma (n = 1). Median hPFS was 240 days, 9 of 10 patients (90%) demonstrated stable disease or partial response to treatment. At a median follow up of 11.5 months, 4 of 10 (40%) remain alive. There were no perioperative mortalities. Myelosuppresion was the most common morbidity, managed on an outpatient basis with growth factors. The median hospital stay was 3 days. CONCLUSIONS: Patients with metastatic melanoma and sarcoma to the liver have limited treatment options. Our experience with PHP demonstrates promising results with minimal morbidity and should be considered (pending FDA approval) as a management option for unresectable melanoma or sarcoma hepatic metastasis.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Chemotherapy, Cancer, Regional Perfusion , Liver Neoplasms/drug therapy , Liver Neoplasms/secondary , Melanoma/drug therapy , Sarcoma/drug therapy , Aged , Chemotherapy, Cancer, Regional Perfusion/instrumentation , Chemotherapy, Cancer, Regional Perfusion/methods , Disease-Free Survival , Eye Neoplasms/pathology , Female , Hepatic Artery , Humans , Infusions, Intra-Arterial , Leiomyosarcoma/drug therapy , Male , Melanoma/secondary , Middle Aged , Retrospective Studies , Sarcoma/secondary , Skin Neoplasms/pathology , Survival Analysis , Treatment Outcome
18.
Cancer Control ; 19(2): 102-12, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22487972

ABSTRACT

BACKGROUND: The high incidence of skeletal metastases in cancer patients warrants careful detection with imaging and follow-up. Efforts are needed to manage pain associated with skeletal metastases as part of overall patient management. METHODS: This article reviews the current methods of diagnostic imaging in the evaluation of skeletal metastases and image-guided treatment of bone metastases for the palliation of pain based primarily on the assessment of imaging and interventional radiologic literature. RESULTS: Approaches to diagnostic imaging of skeletal metastases are summarized. Skeletal scintigraphy provides high sensitivity for detecting skeletal metastases, but targeted computed tomography (CT) or magnetic resonance imaging (MRI) may be needed to increase specificity. Newer imaging modalities, such as positron emission tomography (PET)/CT, improve detection of both lytic and blastic metastases. Minimally invasive percutaneous ablative treatment techniques, including radiofrequency ablation, microwave ablation, and cryoablation, are examined. They provide alternative approaches to radiation therapy to effectively palliate pain of bone metastases. Preliminary results of MR-guided focused ultrasound surgery (MRgFUS) demonstrate its effectiveness in palliating pain from skeletal metastases. CONCLUSIONS: Skeletal scintigraphy is the most common imaging modality for detecting skeletal metastases. Additional imaging may be required based on the type of tumor, the disease state, or treatment options. External-beam radiation therapy remains the mainstay for palliation of pain from bone metastases. Alternative minimally invasive and noninvasive image-guided treatment options can provide effective pain palliation.


Subject(s)
Bone Neoplasms/secondary , Bone Neoplasms/therapy , Bone Neoplasms/diagnosis , Diagnostic Imaging/methods , Humans
19.
J Clin Exp Hepatol ; 12(5): 1259-1263, 2022.
Article in English | MEDLINE | ID: mdl-36157145

ABSTRACT

Background: There is no curative treatment option for patients with unresectable intrahepatic, cholangiocarcinoma (IHC). The aim of this study was to evaluate the efficacy of; radiation segmentectomy/lobectomy using Y90-labeled glass microspheres in patients with; unresectable IHC. Methods: This IRB-approved, single-center study included, 16 patients (age: 67 ± 7.7 years) with IHC who received radiation segmentectomy or lobectomy, treatment using Y90-labeled glass microspheres between May 2009 and October 2019. Radiation, segmentectomy/lobectomy was defined as at least 190 Gy dose delivered into treated liver; volume. Results: The median OS from IHC diagnosis was 22.7 months (95% CI: 13.9-66.1) and from, radioembolization it was 7 months (95% CI: 4.33-54.17). Patients who did not receive, chemotherapy before the radioembolization had significantly longer median OS (26.8 vs. 5.9, months, P = 0.03). Four patients had >20 months survival after radioembolization, including 2, patients with survival of 42 and 54 months. There was no 30-day mortality and no severe, complications. Conclusion: Radiation segmentectomy/lobectomy is safe with minimal side effects. The median, OS of the study group is modest; however, 4 patients (25%) showed excellent survival. These results suggest a need for a larger study to define the IHC patient group who could, most benefit from this procedure.

20.
Adv Radiat Oncol ; 7(1): 100838, 2022.
Article in English | MEDLINE | ID: mdl-35071835

ABSTRACT

PURPOSE: Our purpose was to retrospectively evaluate the safety and efficacy of transarterial hepatic radioembolization (TARE) treatment with yttrium-90 labeled glass microspheres in patients with chemotherapy-refractory breast cancer with liver-dominant metastatic disease. METHODS AND MATERIALS: This retrospective single-institution study evaluated 31 female patients (mean age of 59.6 ± 13.2 years) who were treated with TARE. All patients received and progressed on systemic chemotherapy before TARE. Twenty-one patients also had extrahepatic metastases, including 13 patients who had metastases in bones only besides the liver. Survival data were analyzed by Kaplan-Meier method and compared using log-rank test. Imaging response to treatment was determined by Response Evaluation Criteria in Solid Tumors. RESULTS: Median overall survival (OS) from the TARE was 13 months (95% confidence interval, 9.1-16.9 months). The survival probability at 1, 2, and 3 years was 60.1%, 36.7%, and 24.5%, respectively. The median hepatic progression-free survival was 7 months (95% confidence interval, 6.1-7.9 months). There was no 30-day mortality and 3 patients (9.4%) had grade 3 toxicity. Estrogen receptor (ER) positive status predicted prolonged survival (14 months for ER+ vs 9 months for ER-; P = .028). Patients who had bone-only extrahepatic disease had higher OS than patients with extraosseous metastases (23 vs 8 months, P = .02). At the 3-month follow-up the radiographic objective response rate was 46.6% and disease control rate was 70%. CONCLUSIONS: The treatment of patients with liver-dominant chemotherapy-refractory breast cancer metastases with TARE using yttrium-90 labeled glass microspheres is safe and led to promising hepatic disease control and OS especially in patients with ER+ tumors and in patients without extrahepatic extraosseous metastases.

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